NCT04623970

Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients

Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Accepted

Summary

The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.

Detailed description

This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.

Conditions

• Anxiety Postoperative

Interventions

Type	Name	Description
PROCEDURE	Dental Treatment	Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation

Timeline

• Start date: 2018-11-28
• Primary completion: 2020-01-23
• Completion: 2020-10-05
• First posted: 2020-11-10
• Last updated: 2020-11-13

Locations

1 site across 1 country: Turkey (Türkiye)